Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis (NCT04724980) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis
United States38 participantsStarted 2021-03-16
Plain-language summary
This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.
Who can participate
Age range18 Years
SexALL
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INCLUSION CRITERIA:
* Age 18 years and older
* Clinical diagnosis of RRP
* Histological diagnosis of papilloma confirmed by pathology report from a CLIA-certified (or comparable) laboratory
* Presence of laryngotracheal papillomas with or without pulmonary RRP
* A history of 3 or more interventions in the last 12 months for control of RRP
* Clinical performance status of ECOG of 0-1
* Willing to undergo endoscopic evaluation and operative interventions with biopsies in compliance with this protocol
* No systemic therapy for RRP for at least 3 half-lives of the prior drug(s). A 30-day washout is required for systemic bevacizumab treatment
* Participants who have received prior immunotherapy for RRP are permitted
* Participants must have adequate organ and marrow function as defined below:
* Sexually active subjects (men and women) of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method throughout vaccine treatment and for at least 120 days after vaccine treatment. Highly effective methods are defined as: Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation, and partner's vasectomy; other effective methods are defined as a latex condom, diaphragm, and cervical cap.
* Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests (Hep B DNA quant, HBV viral load), and if confirmatory tests are negative, the pa…
What they're measuring
1
Determine the percentage of subjects with a complete response following treatment with PRGN-2012
Timeframe: 1 year
2
Determine the incidence of dose limiting toxicities to evaluate safety and identify RP2D of PRGN-2012